Philadelphia Chromosome Negative Adult B-cell Acute Lymphoblastic Leukemia Clinical Trial
— GRAALL-2014/BOfficial title:
Multicenter Trial Treatment of Philadelphia Chromosome Negative (Ph-) B-lineage Acute Lymphoblastic Leukemia (ALL) of Young Adults (18-59 Years).
| NCT number | NCT02617004 |
| Other study ID # | AOM12629_3 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | February 2016 |
| Est. completion date | December 2025 |
The purpose of this study is to prospectively validate the new risk model, based on minimal residual disease (MRD) response level and oncogenetic status by comparing historical results of GRAALL-2005 with those of GRAALL-2014 in an identical population of patients (Philadelphia chromosome negative, B lineage ALL, aged 18 to 59 years old).
| Status | Recruiting |
| Enrollment | 500 |
| Est. completion date | December 2025 |
| Est. primary completion date | December 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 59 Years |
| Eligibility |
Inclusion Criteria: 1. Whose blood and bone marrow explorations have been completed before the steroids prephase 2. Aged 18 to 59 years old with not previously treated (including intrathecal injection) B-lineage-ALL newly diagnosed according to the WHO 2008 definition with = 20% bone marrow blasts 3. Whose karyotype shows no t(9;22) and/or the absence in molecular biology of breakpoint cluster region-Abelson (BCR-ABL) 4. With Eastern Cooperative Oncology Group (ECOG) performance status =3 5. With or without central nervous system (CNS) or testis involvement 6. Without other evolving cancer (except basal cell carcinoma of the skin or "in situ" carcinoma of the cervix) or its radiotherapy or chemotherapy treatment should be finished at least since 6 months 7. Having signed a written informed consent 8. With efficient contraception for women of childbearing age (excluding estrogens and IUD) 9. With health insurance coverage 10. Who have received or being receiving the steroid prephase Exclusion Criteria: 1. With lymphoblastic lymphoma and bone marrow blasts < 20%, Burkitt-type ALL, or with antecedents of chronic myeloid leukemia (CML) or other myeloproliferative neoplasm 2. With contra-indication to anthracyclines or any other general or visceral contra-indication to intensive therapy except if considered related to the ALL: - Aspartate transaminase (AST) and/or alanine transaminase (ALT) > 5 x upper limit of normal range (ULN) - Total bilirubin = 2.5 x upper limit of normal range (ULN) - Creatinine >1.5x upper limit of normal range (ULN) or creatinine clearance <50 mL/mn 3. Myocardial infarction within 6 months prior to inclusion in the trial, cardiomyopathy (NYHA grade III or IV), left ventricle ejection fraction (LVEF) < 50% and or Shortening fraction < 30%, 4. Active severe infection or known seropositivity for HIV or human T cell leukemia/lymphoma virus type 1 (HTLV1) or active hepatitis B or C 5. Pregnant (beta-Human Chorionic Gonadotropin positive) or nursing woman 6. Not able to bear with the procedures or the frequency of visits planned in the trial 7. Unable to consent, under tutelage or curators, or judiciary safeguard. |
| Country | Name | City | State |
|---|---|---|---|
| France | Hématologie Adulte, Saint Louis hospital | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Disease free survival (DFS) | 4 years | ||
| Secondary | Cumulative incidence of relapse (CIR) | 4 years | ||
| Secondary | non relapse mortality (NMR) | 4 years | ||
| Secondary | Overall survival | 4 years | ||
| Secondary | Cumulative incidence of relapse (CIR) after censoring at allo-stem cell transplantation (SCT) in first complete remission (CR) | 4 years | ||
| Secondary | overall survival after censoring at allo-stem cell transplantation (SCT) in first complete remission (CR) | 4 years | ||
| Secondary | Non relapse mortality (NRM) after censoring at allo-stem cell transplantation (SCT) in first complete remission (CR) | 4 years | ||
| Secondary | Disease free survival (DFS) after censoring at allo-stem cell transplantation (SCT) in first complete remission (CR) | 4 years | ||
| Secondary | Minimal residual disease (MRD) | 1 year |